MiniMed Group (MMED) risk factors, FY2026 10-K

Business and Operational Risks

1. 01We operate in a highly competitive industry and we may be unable to compete effectively
2. 02Competing products, therapeutic techniques, or other technological developments and breakthroughs for the monitoring, treatment, or prevention of diabetes may render our products obsolete or less desirable
3. 03We have experienced, and may continue to experience, pricing pressure for certain products, which could have a material adverse effect on our business, financial condition, results of operations, and cash flows
4. 04Challenges or delays in the development of new products, including in connection with required government approvals, could adversely affect our business, results of operations, financial condition, and cash flows
5. 05Reduction or interruption in supply or other manufacturing difficulties may adversely affect our manufacturing operations and related product sales
6. 06We obtain some of the components, raw materials, and services needed to manufacture our products from sole suppliers, and the partial or complete loss of one or more of these suppliers could adversely impact our business, results of operations, financial condition, and cash flows
7. 07A U.S. FDA warning letter issued to our sole supplier of infusion sets on January 8, 2026 could result in supply disruption, product recalls, reputational harm, and associated liability, any of which could have a material adverse effect on our business, results of operations, financial condition, and cash flows
8. 08Our current products may not maintain, and our next-generation products may not achieve or maintain market acceptance
9. 09The research and development efforts we undertake may not result in the development of commercially viable products, the generation of significant future revenues, or adequate profitabilit y
10. 10Our success depends on our ability to differentiate our products and keep pace with emerging technologies
11. 11The continuing development of many of our products depends upon our ability to maintain strong relationships with HCPs
12. 12Our results of operations will be harmed if we are unable to accurately forecast market demand for our products and manage our inventory
13. 13If we fail to expand and maintain an effective sales force, predict and adapt to changes in markets, or successfully develop and maintain our relationships with intermediaries, our business, prospects, and brand may be materially and adversely affected
14. 14We enter into co-promotion and other marketing and sales arrangements with other companies. Any revenue received from those arrangements depends on the skills and efforts of others, and we cannot predict whether these efforts will be successful
15. 15Interim, “top-line,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
16. 16Future market or clinical studies may be unfavorable to our products and their efficacy, which could hinder our sales efforts and have a material adverse effect on our business, results of operations, financial condition, and cash flows
17. 17We are subject to a variety of risks associated with global operations that could adversely affect our profitability and operating results
18. 18Failure to secure or retain adequate coverage or reimbursement for our current products and our potential future products by government entities or third-party payors could adversely affect our business, results of operations, financial condition, and cash flows
19. 19We could also experience negative effects on our business, results of operations, financial condition, and cash flows from acquisition-related charges, amortization of intangible assets, and asset impairment charges
20. 20If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operations could be adversely affected, resulting in a decrease in the market price of shares of our common stock
21. 21We may in the future have outstanding debt obligations that could adversely affect our business, results of operations, or financial condition

Legal and Regulatory Risks

1. 22We are subject to extensive and complex laws and governmental regulations and any adverse regulatory action may materially adversely affect our financial condition and business operations
2. 23We are involved in, and may in the future become involved in, litigation, arbitration, and governmental proceedings or investigations, including those stemming from third-party conduct beyond our control
3. 24Quality problems have in the past and could in the future lead to recalls or safety alerts, product liability claims, reputational harm, adverse verdicts, or costly settlements, and could have a material adverse effect on our business, results of operations, financial condition, and cash flows
4. 25Any of the foregoing problems, including future product liability claims or recalls, regardless of their ultimate outcome, could harm our reputation and have a material adverse effect on our business, results of operations, financial condition, and cash flows
5. 26We may be subject to fines, penalties, and injunctions if we are determined to be promoting the use of our products for unapproved or improper off-label uses or determined to have made claims that are untruthful or misleading or not adequately substantiated
6. 27Healthcare policy changes may have a material adverse effect on us
7. 28We are subject to stringent and often unsettled privacy laws, regulations, policies, and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, and contractual obligations could adversely affect our business
8. 29The failure to comply with anti-corruption laws could materially adversely affect our business and result in civil or criminal sanctions
9. 30Laws and regulations governing international business operations could adversely impact our business
10. 31Climate change, or legal, regulatory, or market measures to address climate change, may materially adversely affect our financial condition and business operations
11. 32We are subject to EHS laws and regulations and the risk of environmental liabilities, violations, and litigation
12. 33We are subject to risks related to sustainability practices and initiatives
13. 34The tax laws in the United States and other countries in which we and our affiliates do business could change on a prospective or retroactive basis, and any such changes could have a material impact on our business, results of operations, financial condition, and cash flows
14. 35Our ability to use our net operating losses (“NOLs”) to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liability

Risks Related to the Separation and the Divestment

1. 36We have a limited history of operating as a standalone public company, and our historical financial information included herein may not necessarily reflect the results that we would have achieved as a standalone company or may not be a reliable indicator of our future results
2. 37Following the Separation, our financial profile has changed, and we are a smaller, less diversified company than Medtronic prior to the Separation
3. 38We may not be able to achieve the full strategic and financial benefits expected to result from the Separation, or such benefits may be delayed or not occur at all. The Separation is expected to provide a number of benefits, including those described in this Annual Report
4. 39other actions required to separate the respective businesses could disrupt our operations
5. 40We could experience temporary interruptions in business operations and incur substantial additional costs as we build our information technology infrastructure and transition our data to our own systems
6. 41Our accounting, tax, and other management systems and resources may not be adequately prepared to meet the independent financial reporting, transparency, and other requirements to which we are subject as an independent, publicly traded company
7. 42Medtronic may fail to perform under various transaction agreements entered into in connection with the Separation, or we may fail to have necessary infrastructure, systems, and services in place when certain of the transaction agreements expire
8. 43We may be held liable to Medtronic if we fail to perform certain services or supply obligations under the Transition Services Agreement, and the performance of such services or supply obligations may negatively impact our business and operations
9. 44We may have received better terms from unaffiliated third parties than the terms we received in our agreements with Medtronic
10. 45Under the terms of the Separation, our ability to manage our manufacturing operations is restricted under the terms of the Juncos Lease and Master Services Agreements and the Tax Matters Agreement, and we therefore may not be able to fully conduct these operations in a manner that is optimal for our business
11. 46Following the Divestment, certain of our directors and executive officers may have actual or potential conflicts of interest because of their positions with or financial interests in Medtronic
12. 47The divestment of Medtronic’s remaining equity interest in us may not occur
13. 48Furthermore, if the Divestment does not occur, and Medtronic does not otherwise dispose of its shares of our common stock, the risks relating to Medtronic’s control of us and the potential business conflicts of interest between us and Medtronic will continue to be relevant to our stockholders
14. 49We may be affected by significant restrictions, including on our ability to engage in certain corporate transactions, for a two-year period following the completion of the Divestment, if pursued, in order to avoid triggering significant tax-related liabilities
15. 50The transfer of certain assets and liabilities from Medtronic to us contemplated by the Separation may not be complete prior to the completion of the Divestment and may be significantly delayed or not occur at all
16. 51The assets that we acquired from Medtronic in the Separation may not be sufficient for us to operate as an independent, publicly traded company, and we may experience difficulty in acquiring or separating new assets from Medtronic

Risks Related to Our Relationship with Medtronic

1. 52Medtronic controls the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions
2. 53We are a “controlled company” as defined under the corporate governance rules of Nasdaq and, as a result, qualify for, and rely on, exemptions from certain corporate governance requirements of Nasdaq
3. 54If Medtronic sells a sufficiently large equity interest in us to a third party in a private transaction, such transaction could result in a change of control of us, and you may not realize any change-of-control premium on your shares of our common stock

Risks Related to Our Common Stock

1. 55An active trading market for our common stock may not be sustained
2. 56The price of our common stock may fluctuate substantially, and you could lose all or part of your investment in our common stock as a result
3. 57Future distributions or sales by Medtronic or other holders of shares of our common stock, or the perception that such distributions or sales may occur, including following the expiration of applicable lock-up periods, could cause our common stock’s price to decline
4. 58The distribution or sale by us or Medtronic of a substantial number of shares of our common stock, or a perception that such a distribution or sale could occur, could significantly reduce the prevailing market price of shares of our common stock
5. 59If we are unable to implement and maintain effective internal control over financial reporting in the future, investors could lose confidence in the accuracy and completeness of our financial reports and the market price of shares of our common stock could be adversely affected
6. 60The obligations associated with being an independent publicly traded company require significant resources and management attention
7. 61Your percentage ownership in us may be further diluted in the future
8. 62We are a holding company and our only material assets are our equity interests in our subsidiaries. As a consequence, we depend on the ability of our subsidiaries to pay dividends and make other payments and distributions to us in order to meet our obligations
9. 63We do not expect to pay dividends on our common stock for the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the market price of our common stock
10. 64Certain provisions in our second amended and restated certificate of incorporation and our amended and restated bylaws, and of Delaware law, may prevent or delay an acquisition of us, which could decrease the trading price of our common stock
11. 65Our classified board of directors and other features of our amended and restated certificate of incorporation make it more difficult for our stockholders to remove directors and may prevent our stockholders from effecting a change in the control of our board of directors
12. 66Our second amended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States are the sole and exclusive forum for the resolution of any action asserting a claim arising under the Securities Act